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FEATURED EDITORIAL

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The Complex Anatomy Of An ADC Tech Transfer

Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

GUEST COLUMNISTS

A Much-Improved Approach For Understanding And Managing Safety Risks
Learn how causal mechanism and effect analysis (CMEA) and its principles can be used to develop and maintain safer working environments in the pharma/biotech and medical device industries.
CSV Assumes The AI System Sits Still — It Doesn't.
The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
In Bioprocessing, Trusted Data Is A Process Variable
As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.
Combination Cell Therapy's Clinical Success Hinges On Manufacturability
Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.
Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
June 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.

PHARMA OUTSOURCING WHITE PAPERS

Effective Strategies To Minimize Product Loss During Fill Finish
Every drop of high-value biologic lost in fill finish is money left on the table. Learn practical strategies to protect your yield.

Streamline Your AAV Process With A Production Platform
AAVs are reshaping gene therapy, but scaling production introduces complexity. Learn how upstream process optimization can improve yield, consistency, and speed to meet growing demands.
5 Steps To Design A Microbiological Performance Qualification For Facilities
Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.
Project Management: Sphere Of Influence
The project manager's sphere of influence extends beyond the project team, encompassing the organization, industry, and professional discipline.
Setting The Standard For Plasmid DNA Production
Discover how Boehringer Ingelheim’s expertise in plasmid DNA manufacturing can propel your innovative therapies forward and transform patient care.
Process Analytical Technology In The ADC Bioconjugation Process
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.